MAUDE Adverse Event Report: BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER THERANOVA 400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 115578

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a theranova 400 was observed to be leaking during patient treatment. There was patient involvement, however there was no injury or medical intervention associated with the reported event. No additional information is available.

Manufacturer Narrative

The device was returned for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. Leakage testing was also performed and it was noted that there was a crack in the welding zone. The reported condition was verified. The cause of the reported condition was undetermined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: THERANOVA 400
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): BAXTER HEALTHCARE - HECHINGEN BADEN DIALYZER; hechingen
• MDR Report Key: 8163917
• Report Number: 9611369-2018-00142
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 115578
• Device Lot Number: 8-6602-H-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Treatment(s): NIKKISO DBB-05; NIKKISO DBB-05